FDA Drug · D-1163-2022

Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5

Class II · Terminated

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

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Affected lots / codes — check yours against thisLots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 10/31/22; K21A61 Exp. 11/30/22; L21A45 Exp. 11/30/22
Recalling firm
PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
Classification
Class II (temporary or reversible harm possible)
Status
Terminated
Quantity
1320 bottles
Distribution
Nationwide
Recall initiated
June 6, 2022
Classified
June 27, 2022
Terminated
June 17, 2024
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1163-2022%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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